公司深度分析 2024 年 09 月 09 日 绿竹生物-B(02480.HK) 证券研究报告 生物技术(HS) 投资评级 买入-A 首次评级 6 个月目标价 32.77 港元 股价 (2024-09-05) 21.50 港元 交易数据 总市值(百万港元) 4,352.65 流通市值(百万港元) 4,352.65 总股本(百万股) 202.45 流通股本(百万股) 202.45 12 个月价格区间 17.22/39.0 港元 LZ901 三期进行时，剑指百亿蓝海市场 绿竹生物：深耕行业二十余年，以创新驱动发展。绿竹生物成立于 2001 年 11 月，是一家致力于开发创新型人用疫苗和治疗性生物制剂 的生物技术公司。公司创始人孔健先生曾供职于卫生部北京生物制品 研究所，拥有 30 多年的生物制药行业经验，作为首席科学家带领公 司研究团队实现多项突破，自成立以来成功研发了 6 款疫苗产品，其 中液体 AC 流脑结合疫苗、AC-Hib 三联疫苗为全球首款，Hib 结合疫 苗（磷酸铝佐剂）、ACYW135 流脑多糖疫苗为中国首款，6 款疫苗均已 转让给智飞生物，其中 5 款疫苗已实现商业化。目前，公司共布局了 7 款在 ...

Financial Performance - Total revenue for the six months ended June 30, 2024, was RMB 9,732,000, representing an increase of 82.3% compared to RMB 5,339,000 for the same period in 2023[17]. - The group reported a pre-tax loss of RMB 109,938,000 for the six months ended June 30, 2024, a 38.5% increase from RMB 79,352,000 in 2023[30]. - Other income increased by approximately 82.3% from RMB 5.3 million for the six months ended June 30, 2023, to RMB 9.7 million for the six months ended June 30, 2024, primarily due to unconditional government subsidies[31]. - The company reported a net loss attributable to shareholders of RMB 109,938,000 for the six months ended June 30, 2024, compared to a loss of RMB 79,352,000 for the same period in 2023, representing an increase in loss of approximately 38.7%[92]. - Basic and diluted loss per share for the six months ended June 30, 2024, was RMB 0.54, compared to RMB 0.41 for the same period in 2023, representing a 31.7% increase in loss per share[75]. Research and Development - R&D expenses surged by 142.4% to RMB 80,376,000 from RMB 33,157,000 year-over-year[17]. - The company has developed an innovative antigen delivery technology aimed at enhancing the immunogenicity of vaccine candidates[19]. - The core product LZ901 is part of a pipeline that includes three clinical-stage products and four preclinical-stage products as of June 30, 2024[18]. - The group aims to expand its product pipeline through independent development and collaborations, focusing on clinical development of LZ901, K3, and K193[29]. - The company is focused on the development of its core product LZ901, a recombinant varicella-zoster virus vaccine, which is currently in the research phase[113]. Clinical Trials and Product Pipeline - A Phase III clinical trial for LZ901 has been initiated in China with 26,000 participants aged 40 and above, expected to complete enrollment by January 2024[20]. - K3, a biosimilar to Humira, has completed Phase I trials in China and is set to initiate Phase III trials in 2025[22]. - K193, a bispecific antibody for B-cell leukemia and lymphoma, is in Phase I trials, expected to complete by 2025[23]. - As of June 30, 2024, the group has four products in preclinical stages, including recombinant vaccines for chickenpox and RSV[24]. Financial Position - The total non-current assets as of June 30, 2024, were RMB 536,879,000, a slight decrease from RMB 545,722,000 at the end of 2023[17]. - Cash and bank balances decreased by approximately RMB 77.3 million from RMB 265.0 million as of June 30, 2023, to RMB 187.7 million as of June 30, 2024, primarily due to increased R&D expenditures[41]. - The total assets as of June 30, 2024, were RMB 1,007,513,000, down from RMB 1,070,382,000 as of December 31, 2023, indicating a decrease of 5.9%[76]. - The company's net assets decreased to RMB 944,193,000 as of June 30, 2024, from RMB 1,020,628,000 at the end of 2023, a reduction of 7.5%[76]. - The debt-to-asset ratio was 14.3% as of June 30, 2024, compared to 12.5% as of December 31, 2023[44]. Corporate Governance and Shareholder Information - The company is committed to maintaining high standards of corporate governance to protect shareholder interests[65]. - The company has a significant ownership structure, with Mr. Kong holding a beneficial interest of 28.79% in the company[55]. - The major shareholder, Hengqin Green Bamboo Limited Partnership, holds 12,307,500 shares, representing 6.08% of the total issued share capital[59]. - The company has no directors or senior management with interests in the company's shares or related securities as of June 30, 2024[57]. - The company is focused on enhancing its operational efficiency and financial performance through strategic initiatives and investments[112]. Employee and Operational Insights - As of June 30, 2024, the company employed 148 full-time employees, with 58.8% in R&D roles[51][52]. - Total employee costs increased to RMB 48,752,000 in the first half of 2024, up from RMB 47,410,000 in the same period of 2023, reflecting a rise of about 2.8%[90]. - The company emphasizes employee training to enhance technical and product knowledge across various positions[51]. Future Outlook and Strategic Initiatives - The company plans to submit a Biologics License Application (BLA) for LZ901 to the National Medical Products Administration by January 2025, with commercialization targeted for Q4 2025[20]. - The company is exploring potential mergers and acquisitions to strengthen its competitive position in the industry[112]. - The company plans to continue its research and development efforts to innovate and introduce new products to the market[113].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 Beijing Luzhu Biotechnology Co., Ltd. 北京綠竹生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2480） 截至2024年6月30日止六個月的中期業績公告 北京綠竹生物技術股份有限公司（「本公司」）董事（「董事」）會（「董事會」）欣然宣 佈本公司及其附屬公司（統稱「本集團」）截至2024年6月30日止六個月（「報告期 間」）的未經審核簡明綜合中期業績連同2023年相應期間的比較數字。 1 | --- | --- | --- | --- | |------------------------|--------------------------------------------------|------------------------------------------------------------|----------| | ...

Investment Rating - The investment rating for the company is "Buy" [2][8]. Core Viewpoints - The company is increasing its R&D investment, with a focus on advancing its pipeline. In 2023, the adjusted loss was 223 million yuan, compared to a loss of 152 million yuan in the previous year. R&D expenses for 2023 were 173 million yuan, an increase of 88.9% year-on-year, primarily due to the Phase 3 clinical trial of LZ901 in China [2][5]. - The core product, LZ901, is a recombinant shingles vaccine that has entered Phase 3 clinical trials in China, with 26,000 participants enrolled. The BLA application is expected to be submitted in Q4 2024, with commercialization anticipated in Q4 2025 [2][8]. - The company has adjusted its net profit forecasts for 2024 and 2025 to -300 million yuan and -356 million yuan, respectively, with a new forecast for 2026 at -341 million yuan [2][8]. Financial Forecasts and Metrics - Revenue projections show a significant increase from 1.9 million yuan in 2024 to 244.6 million yuan in 2026, reflecting a growth rate of 1336.0% and 800.4% respectively [1]. - The company is expected to maintain a negative net profit margin, with projected losses continuing through 2026 [1][2]. - The price-to-earnings (P/E) ratio is projected to improve from -15.2 in 2024 to -12.8 in 2025, indicating a potential recovery in earnings [1][2]. Pipeline Progress - The company has multiple products in its pipeline, including K3, a biosimilar to Humira, which is set to enter Phase 3 trials in H2 2024, and K193, a bispecific antibody for treating B-cell leukemia and lymphoma, which is expected to complete Phase 1 trials in H2 2024 [2][5][8]. - As of December 31, 2023, the company has four products in preclinical stages, including a recombinant varicella vaccine and a recombinant RSV vaccine [3][6].

Financial Performance - Total revenue for the year ended December 31, 2023, was RMB 20,085,000, an increase of 44.3% compared to RMB 13,923,000 in 2022[5]. - The company reported a pre-tax loss of RMB 249,350,000, a significant reduction of 65.6% from a loss of RMB 725,180,000 in 2022[5]. - Other income increased by approximately 44.3% from RMB 13.9 million in 2022 to RMB 20.1 million in 2023, primarily due to increased interest income from bank deposits[27]. - The company reported a significant reduction in other expenses, decreasing approximately 80.8% from RMB 3.1 million in 2022 to RMB 0.6 million in 2023[29]. - The net other income increased by approximately 20.3% from RMB 15.1 million in 2022 to RMB 18.2 million in 2023, mainly due to an increase in foreign exchange gains[31]. - The group's pre-tax loss decreased by approximately 65.6% to RMB 249,400,000 for the year ended December 31, 2023, compared to RMB 725,200,000 in 2022[38]. - The liquidity position improved with cash and bank balances increasing from approximately RMB 69,000,000 in 2022 to approximately RMB 265,000,000 in 2023, primarily due to net proceeds from the global offering[43]. - The group incurred listing expenses of approximately RMB 26,500,000 for the year ended December 31, 2023, an increase of approximately 22.8% from RMB 21,500,000 in 2022[37]. Research and Development - Research and development expenses rose to RMB 172,685,000, an increase of 88.9% from RMB 91,426,000 in the previous year[5]. - The company has three clinical-stage products in its pipeline, including the core product LZ901, and four preclinical-stage products[8]. - The company achieved a significant milestone in its R&D pipeline with advancements in multiple products during 2023[9]. - The company plans to actively promote the clinical development of its pipeline drugs, including LZ901, K3, and K193, and accelerate the development of other preclinical products[25]. - The company has established comprehensive internal product discovery capabilities, covering all stages of drug development from preclinical research to manufacturing[22]. - The company is focused on developing innovative human vaccines and therapeutic biological products to prevent and control infectious diseases and treat cancer and autoimmune diseases[76]. - The company is committed to research and development in the field of immunology and protein engineering[76]. - The company has initiated preclinical research for a recombinant RSV vaccine targeting lower respiratory diseases[197]. Clinical Trials and Product Development - The company completed the Phase II clinical trial of LZ901 in China in May 2023 and initiated the Phase III trial in September 2023, involving approximately 26,000 participants, with the first dose expected to be administered by December 2023[10]. - K3, a biosimilar to Humira®, is expected to enter Phase III clinical trials in China in the second half of 2024, with commercialization anticipated in 2026[17]. - K193, a bispecific antibody for treating B-cell leukemia and lymphoma, is expected to complete its Phase I clinical trial by the second quarter of 2024[18]. - The Phase II clinical trial of LZ901 showed significant immunogenicity, with the geometric mean concentration (GMC) and geometric mean titer (GMT) of the high-dose group significantly higher than the low-dose group and the placebo group[15]. - The company has decided to suspend the development of the recombinant rabies vaccine and reallocate resources to the recombinant RSV vaccine, which is currently in the preclinical stage[19]. Production and Facilities - The new production facility in Guangdong covers an area of approximately 120,000 square meters, with 72,000 square meters of production space completed, and is expected to provide an annual capacity of no less than 20 million doses of biological products[11]. - The company received the Drug Production License from the Guangdong Provincial Drug Administration in January 2023, ensuring future commercialization of human vaccines[11]. - The group reported a debt-to-asset ratio of 12.5% as of December 31, 2023, slightly up from 12.4% in 2022[44]. - The group has entered into a construction contract for a new R&D and manufacturing facility with a total construction area of approximately 45,072.87 square meters, expected to enhance its operational capacity[47]. Corporate Governance and Management - The company is led by experienced executives, including Mr. Kong Jian, who has over 35 years in the biopharmaceutical industry and has developed five commercialized vaccines[58]. - The board consists of three executive directors, two non-executive directors, and three independent non-executive directors, ensuring a balanced composition for independent judgment[136]. - The company has established mechanisms to ensure the board receives independent viewpoints, enhancing its ability to protect shareholder interests[139]. - The company has implemented effective procedures for the appointment and re-election of directors, with a term of three years[143]. - The company has established a remuneration committee to determine the remuneration policy for directors and senior management[100]. - The company has adopted a standard code of conduct for securities trading by its directors and supervisors, confirming compliance for the year ended December 31, 2023[154]. - The company emphasizes compliance with legal and regulatory policies as part of its corporate governance responsibilities[156]. Shareholder Information - The total issued share capital of the company as of December 31, 2023, is 202,449,032 shares, comprising 142,719,736 H shares and 59,729,296 non-listed shares[113]. - The company has a significant shareholder, Yitang Saiying, holding approximately 26.60% of the H shares, which equates to 37,969,696 shares[110]. - The employee incentive plan was adopted on December 15, 2021, and all rights under this plan were granted prior to the company's listing[115]. - The company has a diverse shareholder base, with multiple entities holding substantial percentages of H shares, indicating strong institutional interest[110]. - The company has confirmed that there are no other disclosures required under the Securities and Futures Ordinance regarding interests or short positions in shares or related securities[108]. Risks and Challenges - The company has faced major risks and uncertainties, which are discussed in the management discussion and analysis section of the report[78]. - The company anticipates that a majority of its future vaccine products will be sold to China's CDC, exposing it to uncertainties related to government funding and budget processes[81]. - The company may require additional financing to support its R&D and operational expansion, which it may not be able to secure[87]. - The company faces potential liability during the R&D process, particularly from product liability claims or lawsuits[80]. - The company is subject to strict regulations regarding the R&D, manufacturing, and commercialization of its products, which may impact its approval processes[85]. Environmental, Social, and Governance (ESG) - The first Environmental, Social, and Governance (ESG) report was published, detailing the company's management, practices, and performance in ESG matters[189]. - The company aims to maintain transparency and effective communication with investors through various channels, including regular reports and announcements[186]. - The company emphasizes the integration of ESG factors into its operations and decision-making processes[193]. - The company will continue to uphold gender diversity within its workforce[179].

Financial Performance - Total revenue for the year ended December 31, 2023, was RMB 20,085,000, an increase of 44.3% compared to RMB 13,923,000 in 2022[2] - The company reported a pre-tax loss of RMB 249,350,000, a reduction of 65.6% compared to a loss of RMB 725,180,000 in 2022[2] - The net loss for the year was RMB 249,350,000, down from RMB 725,180,000 in the previous year, reflecting a 65.6% improvement[3] - Basic and diluted loss per share for the year was RMB 1.25, compared to RMB 4.98 in 2022[3] - The group incurred a total loss before tax of RMB 249,350,000 for the year ended December 31, 2023, compared to a loss of RMB 725,180,000 in 2022, indicating an improvement in performance[15] - The adjusted loss for the period increased by approximately 46.6% to RMB 222,891,000 for the year ended December 31, 2023, compared to RMB 152,092,000 in 2022, primarily due to increased R&D expenses[66] Research and Development - Research and development expenses rose significantly to RMB 172,685,000, an increase of 88.9% from RMB 91,426,000 in the previous year[2] - The company successfully completed the Phase II clinical trial for LZ901 in China, with no serious adverse events reported[2] - The company plans to initiate a Phase III clinical trial for LZ901 in January 2024, involving approximately 26,000 participants across multiple provinces in China[2] - LZ901, a recombinant herpes zoster vaccine, has shown high immunogenicity and safety in clinical trials, with a geometric mean concentration (GMC) significantly higher in the high-dose group compared to the low-dose group[43] - The Phase II clinical trial of LZ901 was completed in May 2023, and the company plans to submit a Biologics License Application (BLA) to the National Medical Products Administration in Q4 2024[44] - The company has decided to suspend the development of its recombinant rabies vaccine and reallocate resources to the development of a recombinant respiratory syncytial virus (RSV) vaccine[40] - The company has established an innovative protein engineering platform to support the full cycle of drug development, enhancing its capabilities in developing human vaccines and monoclonal antibodies[41] - The company has received IND approval from the FDA for LZ901 and plans to complete the Phase I clinical trial in the U.S. by Q2 2024[44] - The company has three R&D patents and six pending applications related to its core product in China, Russia, and Japan[40] - The company’s proprietary dual-specific antibody development platform, Fabite®, offers competitive advantages in treating recurrent/refractory hematological malignancies[42] - K3, a biosimilar to Humira®, is expected to enter Phase III clinical trials in China in the second half of 2024, with commercialization anticipated in 2026[45] - K193, a bispecific antibody for treating B-cell leukemia and lymphoma, began Phase I clinical trials in China in December 2019, with completion expected in the second half of 2024[46] - The company has four products in preclinical stages, including the recombinant RSV vaccine, which is being prioritized over the rabies vaccine[47] Assets and Liabilities - The company’s total assets increased to RMB 1,070,382,000 as of December 31, 2023, compared to RMB 976,056,000 in 2022[4] - The company’s equity totalled RMB 1,020,628,000, up from RMB 937,466,000 in the previous year[4] - Non-current assets (excluding financial instruments) increased to RMB 545,391,000 as of December 31, 2023, from RMB 468,853,000 as of December 31, 2022[8] - Total property, plant, and equipment increased from RMB 258,046,000 as of December 31, 2022, to RMB 422,831,000 as of December 31, 2023, reflecting a growth of approximately 64%[19] - The company’s accumulated depreciation for property, plant, and equipment increased from RMB 28,419,000 in 2022 to RMB 38,926,000 in 2023[19] - The right-of-use assets increased from RMB 62,462,000 as of December 31, 2022, to RMB 104,591,000 as of December 31, 2023, showing a growth of approximately 67%[21] - The company has a lease liability of RMB 12,216 thousand as of December 31, 2023, which is slightly higher than RMB 11,219 thousand in the previous year, reflecting an increase of approximately 8.9%[33] - The company’s total liabilities related to lease obligations over five years decreased to RMB 5,036 thousand in December 2023 from RMB 6,770 thousand in December 2022, reflecting a decline of approximately 25.7%[33] Cash Flow and Financing - Cash and cash equivalents increased significantly to RMB 257,891 thousand as of December 31, 2023, compared to RMB 68,976 thousand in the previous year, marking an increase of approximately 274%[28] - The company obtained a new bank loan of RMB 10,000,000 in March 2023, with a remaining balance of RMB 7,000,000 after partial repayment in September 2023[36] - Cash and bank balances increased by approximately RMB 196,000,000 to RMB 265,000,000 as of December 31, 2023, from RMB 69,000,000 as of December 31, 2022, mainly due to net proceeds from the global offering[68] - The company completed a public offering on May 8, 2023, raising net proceeds of approximately HKD 241.6 million, equivalent to about RMB 300.18 million[40] - The net proceeds from the global offering amounted to approximately HKD 241.6 million, with no over-allotment option exercised as of May 8, 2023[73] Corporate Governance and Compliance - The company has complied with all applicable corporate governance codes since its listing date[80] - The audit committee reviewed the consolidated financial statements for the year ended December 31, 2023, and discussed matters related to auditing and internal controls[84] - Deloitte has agreed that the figures in the preliminary announcement are consistent with the audited financial statements to be approved on March 15, 2024[85] - The board does not recommend the payment of a final dividend for the year ended December 31, 2023[86] Employee and Operational Insights - A total of 133 full-time employees were employed as of December 31, 2023, with 54.2% in R&D[76] - The production team consists of 28 members, ensuring compliance with quality control standards and regulations[50] - The internal R&D team is involved in all stages of drug development, enhancing the company's capabilities in recombinant protein design and optimization[49] - The company maintains a conservative financing and treasury policy to ensure optimal financial condition and minimal financial risk[78] - The employee incentive plan adopted on December 15, 2021, does not involve the issuance of new shares but grants rights in a partnership[79] Future Plans and Strategic Initiatives - The company plans to expand production capacity to meet growing market demand and accelerate the clinical development of its pipeline products[51] - The company aims to promote the commercialization process both domestically and internationally through strategic planning and partnerships[51] - Funding for ongoing and planned clinical trials of LZ901 in China and the US is set at HKD 97.0 million (40.2%), with HKD 32.8 million already utilized[75] - The company plans to allocate HKD 53.4 million (22.1%) for clinical development and manufacturing of K3, with HKD 38.8 million (16.1%) specifically for planned clinical trials between 2023 and 2024[75]

Financial Performance - The company reported a total revenue of RMB 5,339,000 for the six months ended June 30, 2023, a decrease of 16.1% compared to RMB 6,363,000 for the same period in 2022[6]. - The net loss for the period was RMB 79,352,000, significantly reduced by 87.8% from RMB 652,080,000 in the previous year[6]. - The adjusted loss for the period was RMB 52,893,000, down 39.9% from RMB 88,021,000 in the same period last year[6]. - The total comprehensive loss for the period was RMB 79,352,000, reflecting a substantial improvement compared to the previous year's loss[6]. - The company achieved a net loss before tax of RMB 79.4 million for the six months ended June 30, 2023, representing an 87.8% improvement compared to a net loss of RMB 652.1 million for the same period in 2022[21]. - The company reported a loss attributable to owners of RMB 79,352,000 for the six months ended June 30, 2023, a significant improvement compared to a loss of RMB 652,080,000 for the same period in 2022[90]. - The company reported other income of approximately RMB 5.3 million for the six months ended June 30, 2023, a decrease of 16.1% from RMB 6.4 million for the same period in 2022[22]. - The company reported a significant reduction in other expenses, down 90.3% to RMB 0.3 million for the six months ended June 30, 2023, from RMB 2.9 million in the same period of 2022[24]. Research and Development - The company has three clinical-stage products in its pipeline, including the core product LZ901, and four preclinical-stage products as of June 30, 2023[7]. - The company has established an innovative precision protein engineering platform for drug development, supporting the development of human vaccines and monoclonal antibodies[10]. - LZ901, the company's recombinant shingles vaccine, has shown high immunogenicity and safety in clinical trials, with a geometric mean concentration (GMC) significantly higher in the high-dose group compared to the low-dose group[11]. - The Phase II clinical trial of LZ901 in China was completed in May 2023, with plans to initiate a Phase III trial in Q3 2023 and submit a Biologics License Application (BLA) in H2 2024[11]. - K3, a biosimilar to Humira®, is set to enter Phase III clinical trials in China in Q1 2024, with BLA submission expected in Q4 2024 or Q1 2025[13]. - K193, a bispecific antibody for treating B-cell leukemia and lymphoma, is expected to complete its Phase I trial in Q1 2024 and enter Phase II trials in Q2 2024[14]. - The company has multiple advanced product pipelines, including recombinant vaccines and bispecific antibodies, currently in various stages of clinical development[10]. - The company received IND approval from the FDA for LZ901 in July 2022, indicating progress in its international clinical development strategy[12]. - The company plans to advance clinical development of pipeline products including LZ901, K3, and K193, and to expedite the development of other preclinical products[20]. Financial Position - The company’s total assets as of June 30, 2023, were RMB 1,151,773,000, compared to RMB 937,466,000 as of December 31, 2022[6]. - The company’s equity increased to RMB 1,151,773,000 as of June 30, 2023, up from RMB 937,466,000 at the end of 2022, marking an increase of about 22.8%[74]. - The company's bank balance and cash increased from approximately RMB 690.0 million as of June 30, 2022, to approximately RMB 3,662.0 million as of June 30, 2023, mainly due to net proceeds from the global offering[38]. - The debt-to-asset ratio was 7.9% as of June 30, 2023, compared to 12.4% as of December 31, 2022[39]. - The company’s total liabilities and equity as of June 30, 2023, were reported to be consistent with the fair value of financial assets and liabilities measured at amortized cost[115]. Shareholder Information - As of June 30, 2023, the beneficial ownership of H shares by Hengqin Green Bamboo Limited Partnership is 12,307,500 shares, representing approximately 8.62% of the H shares and 6.08% of the total issued share capital[57]. - Beijing Yizhuang holds 19,645,000 H shares, accounting for approximately 13.76% of the H shares and 9.70% of the total issued share capital[57]. - The total beneficial ownership of H shares by Yitang Saiying is 37,969,696 shares, which constitutes approximately 26.60% of the H shares and 18.76% of the total issued share capital[57]. - The company has a diverse shareholder base, including both domestic and H-share holders[123]. Corporate Governance - The audit committee, consisting of three members, has reviewed the unaudited interim results for the six months ending June 30, 2023, confirming compliance with applicable accounting principles[66]. - The company has complied with all applicable corporate governance code provisions since its listing date up to June 30, 2023[63]. - There have been no arrangements allowing directors or supervisors to benefit from purchasing shares or debt securities of the company during the six months ending June 30, 2023[67]. - The company has not engaged in any major litigation or arbitration as of June 30, 2023[65]. Future Plans and Market Strategy - The company plans to expand the age range for participants in the Phase III trial of LZ901 to include adults aged 40 and above[11]. - The company aims to expand its production capacity to meet growing market demand and to promote commercialization processes domestically and internationally[20]. - The company is exploring market expansion opportunities and potential mergers and acquisitions[123]. - The company anticipates utilizing the net proceeds from the global offering by 2026[48]. Employee Information - The company has employed 129 full-time employees as of June 30, 2023, with 55.8% in R&D[49]. - The company’s production team consisted of 29 personnel as of June 30, 2023, with ongoing training to ensure compliance with quality control requirements[18]. - The company’s quality control team comprised 28 experienced members as of June 30, 2023, all trained in regulatory and GMP standards[19]. Capital Expenditures and Investments - Capital expenditures increased from approximately RMB 135.0 million as of December 31, 2022, to approximately RMB 257.0 million as of June 30, 2023, primarily due to contracted but not yet incurred expenditures for machinery and equipment[40]. - The total capital commitments contracted but not provided for as of June 30, 2023, related to the acquisition of equipment and construction projects amounted to RMB 25,701,000, an increase of 90.5% compared to RMB 13,498,000 as of December 31, 2022[119]. Compliance and Reporting - The company emphasizes compliance with the Hong Kong Stock Exchange listing rules and regulations[123]. - The company is committed to maintaining transparency and accuracy in its financial reporting[123].

Financial Performance - Total revenue for the six months ended June 30, 2023, was RMB 5,339,000, a decrease of 16.1% compared to RMB 6,363,000 in the same period of 2022[2]. - The net loss for the period was RMB 79,352,000, representing an 87.8% reduction from a loss of RMB 652,080,000 in the prior year[2]. - The company recorded no revenue for the six months ended June 30, 2023, consistent with the same period in 2022[11]. - The company reported a net loss attributable to owners of RMB (79,352,000) for the six months ended June 30, 2023, compared to a net loss of RMB (652,080,000) in the same period of 2022, indicating a significant improvement[16]. - The company’s basic and diluted loss per share improved to RMB 0.41 from RMB 6.64 in the same period last year[4]. - The pre-tax loss decreased by approximately 87.8% from RMB 652.1 million in the six months ended June 30, 2022, to RMB 79.4 million in the six months ended June 30, 2023[47]. - The adjusted loss for the period decreased by approximately 39.9% from RMB 880 million in the six months ended June 30, 2022, to RMB 529 million in the six months ended June 30, 2023[50]. Research and Development - Research and development expenses decreased by 39.9% to RMB 33,157,000 from RMB 55,186,000 in the previous period[2]. - The company successfully completed Phase II clinical trials for its core product LZ901 in China, with statistically significant results and good safety profiles[3]. - The company plans to initiate Phase III clinical trials for LZ901 in China in Q3 2023, based on the Phase II trial data[3]. - The company has established an innovative precision protein engineering platform for drug development, supporting the development of human vaccines and monoclonal antibodies[28]. - LZ901, the company's recombinant herpes zoster vaccine, has shown high immunogenicity and safety in Phase II clinical trials, with significant antibody geometric mean concentrations compared to placebo[30]. - The company plans to initiate a Phase III clinical trial for LZ901 in China in Q3 2023 and submit a Biologics License Application (BLA) to the National Medical Products Administration in H2 2024[30]. - The company aims to expand the participant age range for the Phase III trial of LZ901 to adults aged 40 and above in China[30]. - The company has received IND approval from the FDA for LZ901 and plans to complete Phase I trials in the U.S. by Q1 2024[30]. - K3, a biosimilar to Humira®, is expected to enter Phase III clinical trials in Q1 2024 and aims for commercialization by Q4 2025 in China[31]. - K193, a bispecific antibody for B-cell leukemia and lymphoma, is projected to complete Phase I trials by Q1 2024 and enter Phase II trials in Q2 2024[32]. - Other pipeline products include recombinant varicella vaccine and rabies vaccine, with the latter submitting a Pre-IND application in Q4 2023[33]. Expenses and Costs - Administrative expenses decreased by 7.5% to RMB 41,239,000 from RMB 44,603,000 year-on-year[2]. - The company incurred listing expenses of RMB 26,459,000, an increase of 111.5% compared to RMB 12,513,000 in the previous period[2]. - The cost of sales for the immune reagent testing kits was RMB 280,000, down from RMB 348,000 in the previous year, reflecting a 19.5% decrease[13]. - Other expenses significantly decreased by approximately 90.3% from RMB 2.9 million to RMB 0.3 million for the same period, mainly due to the absence of costs related to financial liabilities from a previous financing round[40]. - Financing costs increased by 12.5% from RMB 3 million in the six months ended June 30, 2022, to RMB 4 million in the six months ended June 30, 2023[45]. - Listing expenses increased by approximately 111.5% from RMB 125 million in the six months ended June 30, 2022, to RMB 265 million in the six months ended June 30, 2023[46]. Assets and Liabilities - The total assets as of June 30, 2023, were RMB 1,250,495,000, compared to RMB 1,070,170,000 as of December 31, 2022[5]. - The company’s net asset value increased to RMB 1,151,773,000 from RMB 937,466,000 year-on-year[5]. - The estimated unused tax losses as of June 30, 2023, were approximately RMB 242,129,000, up from RMB 170,512,000 as of December 31, 2022[15]. - Right-of-use assets increased by RMB 46,622,000 during the reporting period, reflecting investments in R&D and commercial production facilities in Beijing[18]. - The construction in progress for commercial production facilities in Zhuhai and Beijing increased by RMB 42,846,000 and RMB 77,277,000, respectively, during the reporting period[19]. - Total prepayments and other receivables decreased significantly to RMB 42,311,000 as of June 30, 2023, from RMB 190,469,000 as of December 31, 2022[20]. - The company obtained a new bank loan of RMB 10,000,000 at an annual interest rate of 2.35%, due within one year[22]. - As of June 30, 2023, the total deferred government grants amounted to RMB 34,186,000, a decrease from RMB 36,771,000 as of December 31, 2022[23]. - The company reported a capital expenditure commitment of RMB 25,701,000 for equipment and construction projects as of June 30, 2023, compared to RMB 13,498,000 as of December 31, 2022[27]. - The debt-to-asset ratio decreased to 7.9% as of June 30, 2023, compared to 12.4% as of December 31, 2022[52]. Corporate Governance and Compliance - The company has complied with all applicable corporate governance codes since the listing date[60]. - The company emphasizes the importance of regulatory compliance with the National Medical Products Administration in China[67]. - The company aims to comply with Good Manufacturing Practices (GMP) to ensure quality assurance in its production processes[66]. - The company is committed to reducing risks of contamination and errors in drug production through adherence to regulatory guidelines[66]. - The board of directors includes key figures such as Mr. Kong Jian, who serves as the executive director and chairman[68]. Employee and Organizational Structure - The company employed 129 full-time employees as of June 30, 2023, and has established a performance evaluation system for employee assessments[58]. - The employee incentive plan adopted prior to the listing does not involve the issuance of new shares or options[59]. - The production team consists of 29 members, and the quality control team has 28 members, both trained in regulatory and GMP standards[36]. Capital and Funding - The net proceeds from the global offering amounted to approximately HKD 241.6 million, after deducting underwriting commissions and other expenses[55]. - As of June 30, 2023, the allocation of net proceeds from the global offering includes HKD 140.7 million (58.2%) for clinical development, manufacturing, and commercialization of core product LZ901[56]. - Funding for ongoing and planned clinical trials of LZ901 in China and the U.S. is allocated HKD 97.0 million (40.2%)[56]. - The company expects to fully utilize the net proceeds from the global offering by 2026[58]. Stock and Listing Information - The company’s H-shares were listed on the Hong Kong Stock Exchange on May 8, 2023[67]. - The company’s shares have a par value of RMB 1.00 each, with both domestic and H-shares included in its capital structure[68]. - The board did not recommend an interim dividend for the six months ended June 30, 2023, consistent with the previous year[54].